FDA.reportPublic FDA data

ACE

Primary DI
00614950031405
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
1000226
Catalog number
1000226
Device description
"LUCAS BONE CURETTE SERRATED ANG 4.5MM 7 TEETH 6-1/2"" 17CM"
Published
2023-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKTCURETTE, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKTCurette, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950031405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950031405006149500314056149500314050614950031405

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100regulatoryandquality@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950007547OUSIA bioXENOUSM2OUSM22015-10-24
00614950007554OUSIA bioXENOUSM3OUSM32015-10-24
00614950007561OUSIA bioXENOUSM4OUSM42015-10-24
00614950007578OUSIA bioXENOUSM5OUSM52015-10-24
00614950007585OUSIA bioXENOUSM6OUSM62015-10-24
00614950007721OUSIA bioXENOUSM1OUSM12015-10-24
00614950027910Collagen Matrix509400150940012023-06-16
00614950027927Collagen Matrix509400250940022023-06-16
00614950027934MinerOss® XBH0034BH00342022-10-27
00614950027941MinerOss® XBH0035BH00352022-10-27
00614950027958MinerOss® XBH0036BH00362022-10-27
00614950027965MinerOss® XBH0037BH00372022-10-27
00614950027972MinerOss® XBH0038BH00382022-10-27
00614950027989MinerOss® XBH0039BH00392022-10-27
00614950027996MinerOss® XBH0044BH00442022-10-27
00614950028009MinerOss® XBH0045BH00452022-10-27
00614950028016MinerOss® XBH0046BH00462022-10-27
00614950028023MinerOss® XBH0047BH00472022-10-27
00614950028030MinerOss® XBH0052BH00522022-10-27
00614950028047MinerOss® XBH0053BH00532022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB2060TBS BASICSACME ENTERPRISE.EKT2026-05-16
G149TBSB2070TBS BASICSACME ENTERPRISE.EKT2026-05-16
G149TBSB2080TBS BASICSACME ENTERPRISE.EKT2026-05-16
G149TBSB2090TBS BASICSACME ENTERPRISE.EKT2026-05-16
00810123209682Adler Instrument CompanyAdler, Inc.EKT2025-12-08
00190776410643MillenniumAvalign Technologies, Inc.EKT2025-09-11
00190776409166MillenniumAvalign Technologies, Inc.EKT2025-08-22
00190776405304MillenniumAvalign Technologies, Inc.EKT2025-07-15
00810123208340Adler Instrument CompanyAdler, Inc.EKT2025-01-27
00190776075002AvalignAvalign Technologies, Inc.EKT2023-11-13
00190776075019AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287412AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287429AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287436AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287498AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776351359MILLENNIUMAvalign Technologies, Inc.EKT2023-09-28
00190776372606AvalignAvalign Technologies, Inc.EKT2023-09-28
00810123202362Adler Instrument CompanyAdler, Inc.EKT2023-03-16
00190776363277MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363284MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363291MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363307MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363314MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363321MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363338MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363345MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363352MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363369MillenniumAvalign Technologies, Inc.EKT2023-02-22